Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

NCT01874054 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-02-12

Study results available
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Summary

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

Conditions

  • Hodgkin Disease

Interventions

DRUG

brentuximab vedotin

1.8 mg/kg every 3 weeks by intravenous (IV) infusion

DRUG

bendamustine

90 mg/m2 on Days 1 and 2 of 3-week cycles

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Neil Josephson, MD · Seagen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-12-31
Completion
2018-02-20

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874054 on ClinicalTrials.gov